Description

Indapamide Impurity 10 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for the quality control and regulatory compliance of the active pharmaceutical ingredient (API) Indapamide, a diuretic medication. It is primarily required by analytical laboratories, pharmaceutical manufacturers, and regulatory bodies for method validation, stability studies, and impurity profiling. Understanding the nature and behavior of Indapamide Impurity 10Q: What Is Indapamide Impurity 10 Q: What Is The Cas Number Of Indapamide Impurity 10 is essential for ensuring drug safety and efficacy.

Application

• Pharmaceutical Reference Standard: Serves as a certified standard for the identification and quantification of impurities in Indapamide API and finished dosage forms.
• Analytical Method Development & Validation (HPLC/LC-MS): Used as a critical component in developing and validating chromatographic methods for impurity separation and analysis.
• Stability Indicating Studies: Employed to monitor the formation of this specific degradant during forced degradation and long-term stability studies of Indapamide.
• Quality Control & Batch Release Testing: Essential for routine QC testing to ensure Indapamide batches meet stringent pharmacopeial (e.g., USP, EP) impurity limits.
• Regulatory Submissions: Required for compiling impurity data in regulatory filings (e.g., ANDA, NDA, CMC dossiers) for FDA, EMA, and other health authorities.
• Research on Degradation Pathways: Used in research to elucidate the chemical pathways leading to the formation of this impurity.

Basic Information

Product Name	Indapamide Impurity 10
CAS No.	2457316-06-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Indapamide Related Compound 10; Indapamide Impurity Q; 4-Chloro-N-(2-methyl-2,3-dihydro-1H-indol-1-yl)-3-sulfamoylbenzamide Impurity; 1-(4-Chloro-3-sulfamoylbenzoyl)-2-methylindoline Impurity; Indapamide Degradant; Indapamide Process Impurity; API Impurity of Indapamide
EINECS	Contact for details

Quality Control

Our Indapamide Impurity 10 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and identity verification by spectroscopic methods (IR, MS, NMR). We provide comprehensive Certificates of Analysis (COA) with batch-specific data, ensuring traceability and compliance with ICH guidelines for impurities in new drug substances (Q3A(R2)). Our standards are suitable for use in GMP/GLP environments.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing desiccated at 2-8°C.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.